30 April 2024

PBR

'New Genomic Techniques and Intellectual Property Law: Challenges and Solutions for the Plant Breeding Sector ‒ Position Statement of the Max Planck Institute for Innovation and Competition: Munich, 8 January 2024' by Daria Kim, Michael A Kock, Matthias Lamping, Pedro Henrique D Batista, Reto M Hilty, Peter R Slowinski and Miriam Steinhart in (2024) 73(4) GRUR International 323–339 comments 

On 5 July 2023, the European Commission proposed a regulation aiming to ease the requirements for the marketing authorisation of plants obtained through certain new genomic techniques (NGTs) within the European Union (EU). While NGTs are expected to become more attractive to breeders and farmers, the complexity of the intellectual property (IP) landscape surrounding these techniques and resulting products may negatively impact technology diffusion and innovation. Given numerous concerns related to IP protection for NGTs and NGT-derived plants, this Position Statement from the Max Planck Institute for Innovation and Competition presents a set of policy recommendations for facilitating access to and utilisation of IP-protected NGTs and NGT-derived products in the breeding sector. 

New genomic techniques (NGTs) have the potential to transform traditional plant breeding, resulting in significant social benefits, in particular, by improving global food security and mitigating the impact of climate change. However, NGTs also pose new legal challenges, especially in terms of safety regulation and intellectual property (IP) regimes. 

The recent Proposal by the European Commission (hereinafter ‘the Commission’) for a Regulation on plants obtained by certain NGTs and their products4 envisages treating NGT-derived plant varieties largely as products derived from conventional (random) mutagenesis. This is expected to make NGTs more attractive to breeders and farmers, as well as increase competition among companies utilising NGTs. As a result, the need for access and usage rights in IP-protected NGTs and NGT-derived plant varieties is likely to become more urgent. Notably, the Commission has acknowledged concerns related to IP protection, in particular, raised by ‘breeders and farmers’ organisations regarding the need to ensure breeders’ access to patented genetic material and access by […] farmers to [plant reproductive material] from NGT plants’. 

This Position Statement addresses some of the concerns regarding patents and plant variety protection for NGTs and NGT-derived plants, focusing on the plant breeding sector and the applicable EU legal framework. Most of the proposed solutions can be implemented through clarifications of existing legal provisions, while some may require legislative measures or private ordering coordination. Overall, these solutions aim to mitigate the deterrence effect caused by the complexity of the IP landscape surrounding NGTs and NGT products, in particular, by facilitating the allocation of access and usage rights.